DRAFT FOR PUBLIC CONSULTATION Integrated Impact …

DRAFT FOR PUBLIC CONSULTATION

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Integrated Impact Assessment Report for Clinical Commissioning Policies

Policy Reference Number A02X05

Policy Title Chemosaturation for liver metastases from ocular melanomas

Accountable Commissioner Ursula Peaple Clinical Lead Graeme Poston

Finance Lead Robert Cornall, Craig Holmes Analytical Lead Ceri Townley

Section K - Activity Impact

Theme Questions Comments (Include source of information and details of assumptions made and any issues with the data)

K1 Current Patient Population & Demography / Growth

K 1.1 What is the prevalence of the disease/condition?

K1.1 This policy proposes a non-routine commissioning position for chemosaturation for the treatment of liver metastases from ocular melanoma primary cancers.

Ocular melanoma (OM) is a rare form of eye cancer that predominantly affects the uvea. In the UK, it is estimated that between 500 and 600 people are diagnosed with uveal melanoma each year. i For England, this represents c.420-505 patients in 2014/15.ii


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K1.2 What is the number of patients currently eligible for the treatment under the proposed policy?

K1.2 The number of patients eligible for treatment is a subset of the prevalent population; those with uveal melanoma with metastatic liver disease isolated predominantly to the liver. Of the 420-505 patients with uveal melanoma identified in K1.1, is it estimated thatiii:

Between 30 and 50% (c. 125-250 patients) may suffer a recurrence of their cancer within 5-10 years of diagnosis associated with metastatic liver disease.

Of these around 70% (c. 90 to 175) may have metastasis isolated predominantly to the liver.iv

Of these patients, it is estimated that around 50-75 would be suitable for chemosaturation each year.v

K1.3 What age group is the treatment indicated for?

K1.3 The treatment is indicated for adults (aged 18 years and over).

K1.4 Describe the age distribution of the patient population taking up treatment?

K1.4 The average age of onset of uveal melanomas is estimated to be 55vi and the average age of a patient is estimated to be around 60vii.

K1.5 What is the current activity associated with currently routinely commissioned care for this group?

K1.5 For patients with OM liver metastases, there is no standard practice and the Metastatic Uveal Melanoma MDT reviews each patient on a case-by-case basis to determine next best course of intervention.viii The treatment for the patient will depend on the stage and location of the cancer, and how well the liver function is preserved.ixIf metastases are detected early, there are interventions that potentially extend life expectancy and improve quality of life. These includex:

surgical resection;

thermal ablation;


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systemic therapy;

selective internal radiation therapy (SIRT); and

transarterial chemoembolisation (TACE).

Chemosaturation is currently used in some patients who are not amenable to treatments such as surgical resection and thermal ablation.xi It is estimated that around 22-23 patients received chemosaturation in 2014/15.xii xiii

The remaining patients in the target population from K1.2 (who would be eligible for chemosaturation but do not currently receive currently it) are expected to receive either:xiv

systemic therapyxv; or

TACE, only to selected patients.xvi

K1.6 What is the projected growth of the disease/condition prevalence (prior to applying the new policy) in 2, 5, and 10 years?

K1.6 Internationally, the incidence of uveal melanoma has remained stable over the last 30 years or so.xvii xviii Therefore, no future change to incidence of uveal melanoma is anticipated, and the population with uveal melanoma may grow in line with population growth and is estimated to bexix:

~ 425 - 510 in 2016/17 (year 1)

~ 430 - 515 in 2017/18 (year 2)

~ 440 - 525 in 2018/19 (year 5)

K1.7 What is the associated projected growth in activity (prior to applying the new policy) in 2,5 and 10 years

K1.7 Under a do-nothing scenario, the activity for chemosaturation is anticipated to grow in line with the population growth and is estimated to be broadly stable over the next five years atxx:

~ 22-23 in 2016/17 (year 1)


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~ 22-23 in 2017/18 (year 2)

~ 23-24 in 2020/21 (year 5)

K1.8 How is the population currently distributed geographically?

K1.8 No evidence on the geographic distribution of ocular melanoma in the UK or England has been identified within this review.

K2 Future Patient Population & Demography

K2.1 Does the new policy: move to a non-routine commissioning position / substitute a currently routinely commissioned treatment / expand or restrict an existing treatment threshold / add an additional line / stage of treatment / other?

K2.1 This policy proposes a non-routine commissioning position.

K2.2 Please describe any factors likely to affect growth in the patient population for this intervention (e.g. increased disease prevalence, increased survival)

K2.2 No factors have been identified in this review.

K 2.3 Are there likely to be changes in geography/demography of the patient population and would this impact on activity/outcomes? If yes, provide details

K2.3 No changes have been identified.


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K2.4 What is the resulting expected net increase or decrease in the number of patients who will access the treatment per year in year 2, 5 and 10?

K2.4 The proposed policy establishes a ‘not routinely commissioned’ proposal for the relevant population (the specific cohort set out in K1.2). The number of patients who fall outside of the cohort covered by the proposed policy, or for whom exceptionality might be demonstrated is likely to be very small.

As such there is expected to be a net decrease in the number of patients accessing the treatment each year. As activity is expected to be zero in future years, the decrease in activity is equal to the estimated future activity in the ‘do nothing’ case, as identified in K1.7:

~ 22-23 in 2016/17 (year 1)

~ 22-23 in 2017/18 (year 2)

~ 23-24 in 2020/21 (year 5)

For these patientsxxi:

~ 8-10 are expected to receive TACE; and

~ 13-14 patients are expected to receive systemic therapy (chemotherapy either with or without immunotherapy).

The activity for these patients further along the pathway could be different when compared to the ‘do-nothing’. This may be dependent on two factorsxxii:

i. The comparative response rate of the treatments. If the response rate of chemosaturation is greater than that of the comparative treatments, then more patients may require further line treatments such as systemic therapy and palliative care when compared to the ‘do-nothing’.

ii. How much each treatment increases the length of survival.

However given the uncertainty in treatment options and outcomes, there is limited evidence to quantify the impacts in the subsequent stages of the pathway.


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K3 Activity K3.1 What is the current annual activity for the target population covered under the new policy? Please provide details in accompanying excel sheet

K3.1 Current annual activity is identified in K1.5.

K3.2 What will be the new activity should the new / revised policy be implemented in the target population? Please provide details in accompanying excel sheet

K3.2 Future chemosaturation activity for the target population is expected to be zero in future years given a non-routinely commissioned position. As identified in K2.4, instead these patients are expected to receive either TACE or systemic therapy.

K3.3 What will be the comparative activity for the ‘Next Best Alternative’ or 'Do Nothing' comparator if policy is not adopted? Please details in accompanying excel sheet

K3.3 The activity under the ‘Do Nothing’ is as described in K1.7.

K4 Existing Patient Pathway K4.1 If there is a relevant currently routinely commissioned treatment, what is the current patient pathway? Describe or include a figure to outline associated activity

K4.1 – K4.2 Once liver metastasis are confirmed the patient will be referred to a specialist metastatic uveal melanoma multi-disciplinary team (MDT). The MDT is comprised of interventional radiologists, oncologists, HPB surgeons, cancer nurse specialists, anaesthetists and occasionally pathologists. This MDT receives referrals from ophthalmology oncologists, medical oncologists and hepatobiliary MDTs and is responsible for deciding, with the patient, the best management approach. The MDT may undertake further imaging including PET CT scanning and cardiopulmonary exercise tolerance testing although these are occasionally undertaken by the referring team.

After full assessment of the patient, the MDT will consider whether surgical resection, thermal ablative therapy, systemic chemotherapy, SIRT, immunotherapy or chemosaturation is the most suitable. For liver only (intrahepatic) metastases,


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surgical resection or thermal ablative therapy would be the preferred treatment options, as these would result in tumour removal. However there are estimated to be less than 10% of patients who would be suitable for these interventions. The MDT will be required to decide if chemosaturation represents the best opportunity for prolonging life and improving quality of life. Patients with significant cardiac history, respiratory disease, brain metastases, abnormal liver anatomy or high risk of bleeding elsewhere will be unable to undergo chemosaturation, as determined by the MDT. Patients with extrahepatic metastasis may require a systemic therapy as first-line, either as immunotherapy or systemic chemotherapy.

K4.2. What are the current treatment access criteria?

K4.3 What are the current treatment stopping points?

K4.3 Metastases from ocular melanoma is a palliative condition and therefore all patients will require palliative, and eventually end of life care.

Current stopping points from active treatment (to palliative care) are:

(1) Following surgical or thermal ablative therapy

(2) Following systemic chemotherapy

K5 Comparator (next best alternative treatment) Patient Pathway

K5.1 If there is a ‘next best’ alternative routinely commissioned treatment what is the current patient pathway? Describe or include a figure to outline associated activity.

K5.1 – K5.2 as K4.1-4.2

K5.2 Where there are different stopping points on the pathway please indicate how many patients


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out of the number starting the pathway would be expected to finish at each point (e.g. expected number dropping out due to side effects of drug, or number who don’t continue to treatment after having test to determine likely success). If possible please indicate likely outcome for patient at each stopping point.

K6 New Patient Pathway K6.1 Describe or include a figure to outline associated activity with the patient pathway for the proposed new policy

K6.1 Not applicable as chemosaturation is proposed to be not routinely commissioned.

K6.2 Where there are different stopping points on the pathway please indicate how many patients out of the number starting the pathway would be expected to finish at each point (e.g. expected number dropping out due to side effects of drug, or number who don’t continue to treatment after having test to determine likely success). If possible please indicate likely outcome for patient at each stopping point.


K7 Treatment Setting K7.1 How is this treatment delivered to the patient?

K7.1 Chemosaturation therapy may be performed in an interventional radiology department and patients may stay in a level 2xxiii or level 3xxiv care unit for one night, with a subsequent 1 or 2 night stay on the ward.xxv


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o Acute Trust: Inpatient/Daycase/

Outpatient

o Mental Health Provider: Inpatient/Outpatient

o Community setting

o Homecare delivery

K7.2 Is there likely to be a change in delivery setting or capacity requirements, if so what?

e.g. service capacity


K8 Coding K8.1 In which datasets (e.g. SUS/central data collections etc.) will activity related to the new patient pathway be recorded?


K8.2 How will this activity related to the new patient pathway be identified?(e.g. ICD10 codes/procedure codes)

K8.2 Not applicable chemosaturation is proposed to be not routinely commissioned.

K9 Monitoring K9.1 Do any new or revised requirements need to be included in the NHS Standard Contract Information Schedule?



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K9.2 If this treatment is a drug, what pharmacy monitoring is required?


K9.3 What analytical information /monitoring/ reporting is required?


K9.4 What contract monitoring is required by supplier managers? What changes need to be in place?


K9.5 Is there inked information required to complete quality dashboards and if so is it being incorporated into routine performance monitoring?


K9.6 Are there any directly applicable NICE quality standards that need to be monitored in association with the new policy?


K9.7 Do you anticipate using Blueteq or other equivalent system to guide access to treatment? If



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so, please outline. See also linked question in M1 below

Section L - Service Impact


L1 Service Organisation L1.1 How is this service currently organised? (i.e. tertiary centres, networked provision)

L1.1 Two metastatic uveal melanoma MDTs exist in tertiary centres nationwide. These MDTs are currently responsible for deciding the most appropriate next treatment step on a case-by-case basis.

L1.2 How will the proposed policy change the way the commissioned service is organised?

L1.2 Not applicable as chemosaturation is proposed to be not routinely commissioned.

L2 Geography & Access L2.1 Where do current referrals come from?

L2.1 Referrals typically come from ophthalmologists, hepatobiliary MDTs and oncology MDTs.

L2.2 Will the new policy change / restrict / expand the sources of referral?


L2.3 Is the new policy likely to improve equity of access

L2.3 As chemosaturation is not being routinely commissioned; equity of access will remain unchanged.

L2.4 Is the new policy likely to improve equality of access /

L2.4 As chemosaturation is not being routinely commissioned; equality of access will


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outcomes? remain unchanged.

L3 Implementation L3.1 Is there a lead in time required prior to implementation and if so when could implementation be achieved if the policy is agreed?


L3.2 Is there a change in provider physical infrastructure required?


L3.3 Is there a change in provider staffing required?


L3.4 Are there new clinical dependency / adjacency requirements that would need to be in place?


L3.5 Are there changes in the support services that need to be in place?


L3.6 Is there a change in provider / inter-provider governance required? (e.g. ODN arrangements



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/ prime contractor)

L3.7 Is there likely to be either an increase or decrease in the number of commissioned providers?


L3.8 How will the revised provision be secured by NHS England as the responsible commissioner? (e.g. publication and notification of new policy, competitive selection process to secure revised provider configuration)


L4 Collaborative Commissioning L4.1 Is this service currently subject to or planned for collaborative commissioning arrangements? (e.g. future CCG lead, devolved commissioning arrangements)


Section M - Finance Impact



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M1 Tariff M1.1 Is this treatment paid under a national prices*, and if so which?

M1.1 There is no specific tariff or NHS funding stream for chemosaturation and it is expected that current activity may be funded using the tariff price used for TACE (as a proxy) as well as through unbundled codes for ICU bed days.xxvi

The cost per cycle of chemosaturation is estimated to be in the region of £22,000 to £23,000 including the device, radiology and inpatient costs. This is expected to break down asxxvii:

~ £4,000 for the bypass;

~ £5,000 for the procedure (this is recorded under the same as tariff as TACE)xxviii;

~ £2,000 for ICU bed days; and

~ £11,000 - £12,000 for the device.

M1.2 Is this treatment excluded from national prices

M1.2 Please refer to M1.1.

M1.3 Is this covered under a local price arrangements (if so state range), and if so are you confident that the costs are not also attributable to other clinical services?

M1.3 The device would be excluded from national prices and the price would be agreed locally; with a full price of c. £11,000 - £12,000.xxix

M1.4 If a new price has been proposed how has this been derived / tested? How will we ensure that associated activity is not additionally / double charged through existing routes?

M1.4 Not applicable.


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M1.5 is VAT payable (Y/N) and if so has it been included in the costings?

M1.5 VAT would be recoverable under certain specific conditionsxxx. It is assumed here that VAT would not be recoverable.

M1.6 Do you envisage a prior approval / funding authorisation being required to support implementation of the new policy?


M2 Average Cost per Patient M2.1 What is the revenue cost per patient in year 1?

M2.1 With a non-routine commissioning position, the cost per patient for chemosaturation under the policy would be nil. For reference, the cost per patient for chemosaturation would typically comprisexxxi:

1. Pre assessment. Prior to the procedure patients may require:

a. A CT scan of the chest or abdomen, at an estimated cost of between c. £85 and £150.xxxii

b. An MRI scan of the liver, at an estimated cost of between c. £150 and £330.xxxiii

c. A CT scan of the brain, at an estimated cost of between c. £85 and £150xxxiv

d. In some cases an angiogram would be required, at an estimated cost c. £2,225.xxxv xxxvi

Total pre-assessment costs could therefore range between £320 and £2,850.

2. Chemosaturation. As identified in M1.1, the cost per cycle of chemosaturation is in the region of £22,000 to £23,000. On average, patients would complete between 1 and 3 cycles of chemosaturation, with a median of 2xxxvii. This would therefore cost between £22,000 and £69,000 per patient, with a median cost of £45,500.

3. Follow-up. Following chemosaturation, a patient would be expected to be


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closely followed up every 3 months for the first 6 to 12 months, where they may receive an MRI or CT scan. Patients would previously have been seen either once or twice a year.xxxviii This could cost between £170 and £1,315 per year.xxxix

For a patient receiving chemosaturation, the cost in year 1, excluding further treatments, could therefore range between c. £22k and £73k, with a mid-estimate of c. £48k.xl

However, as chemosaturation is proposed to be not routinely commissioned, these patients would be expected to receive either TACE or systemic therapy, as described in K2.4.

For TACE, the cost per patient would typically comprise:

1. Pre assessment. Prior to the procedure, patients may require:

a. A CT scan of the chest or abdomen, at an estimated cost of between c. £85 and £150.xli

b. An MRI scan of the liver, at an estimated cost of between c. £150 and £330.xlii

Total pre-assessment costs could therefore range between £235 and £480.

2. TACE, which has an estimated cost per cycle of c. £5,000.xliii xliv The number of cycles typically ranges between 2 and 4, with a median of 3xlv, resulting in estimated per patient costs ranging between £10,000 and £20,000, with a median of £15,000. Unlike for chemosaturation, no bypass or ITU bed days would be required and it is expected that there would be an increased likelihood of adverse impacts in the form of increased pain and readmissions when compared to chemosaturation.xlvixlvii

3. Follow-up. As with chemosaturation, a patient would be expected to be closely followed up every 3 months for the first 6 to 12 months, where they may receive an MRI or CT scan. Patients would previously have been seen either once or twice a year.xlviii This could cost between £170 and £1,315 per


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year.xlix

The total cost per patient for TACE could therefore be in the region of £10k and £22k, with a median of £16k.l

For systemic therapy, patients could receive either:

1. Systemic chemotherapy, with an estimated cost of c. £4kli; or 2. Systemic chemotherapy with immunotherapy, with an estimated per patient

cost of c. £35k - £79k.lii The total cost per patient for systemic therapy could therefore range between c. £4k and £79k. Were 50% of patients to receive each option, a mid-cost estimate could be c. £30k.

M2.2 What is the revenue cost per patient in future years (including follow up)?

M2.2 Following the first year of treatment, patients may receive an MRI scan every 4 months. The number of subsequent MRI scans, and more generally the cost of care in future years, is dependent on the length of survival in each patient, and is likely to vary greatly across the patient group.liii

M3 Overall Cost Impact of this Policy to NHS England

M3.1 Indicate whether this is cost saving, neutral, or cost pressure to NHS England

M3.1 The policy is to not routinely commission this treatment. The 22-23 net decrease in patients receiving chemosaturation each year identified in K2.4 would lead to an estimated annual cost saving to NHS England in the region of £1.1m.liv

The reduced use of chemosaturation would lead to an increase in comparator activity as outlined in K2.4. This could offset the cost saving by c. £0.5 - £0.6m annually.lv

The net financial saving could therefore be in the region of £0.5m annuallylvi.

Following these treatment options, further costs could be incurred. As described in K2.4, the full cost impact would therefore depend on how activity differs in later stages of the pathway for patients who would have received chemosaturation in the


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‘do nothing’ who now would receive TACE or systemic chemotherapy. Given the uncertainty in the subsequent treatment options and also in outcomes (including mortality) it has not been possible to quantify this. Please refer to M6.1.

M3.2 Where this has not been identified, set out the reasons why this cannot be measured


M4 Overall cost impact of this policy to the NHS as a whole

M4.1 Indicate whether this is cost saving, neutral, or cost saving for other parts of the NHS (e.g. providers, CCGs)

M4.1 This is expected to be cost neutral to other parts of the NHS.

M4.2 Indicate whether this is cost saving, neutral, or cost pressure to the NHS as a whole

M4.2 As discussed in M3.1, there is expected to be a direct cost saving to the NHS as a whole of c. £0.5m per year.

M4.3 Where this has not been identified, set out the reasons why this cannot be measured


M4.4 Are there likely to be any costs or savings for non NHS commissioners / public sector funders?

M4.4 None expected.

M5 Funding M5.1 Where a cost pressure is indicated, state known source of



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funds for investment, where identified e.g. decommissioning less clinically or cost-effective services

M6 Financial Risks Associated with Implementing this Policy

M6.1 What are the material financial risks to implementing this policy?

M6.1. As discussed in K2.4, patients who no longer receive chemosaturation under the policy would be expected to instead receive systemic chemotherapy (either with or without immunotherapy).

Depending on the outcomes from these treatments, patients could incur future costs further down the pathway. Given the uncertainty around how patients would be treated in future in the ‘do-nothing’ and with the policy and their comparative outcomes, this has not been quantified.

Future stages of the pathway could includelvii:

No treatment where there has been a good response;

Palliative care where they do not respond;

Where patients do not achieve remission and the cancer returns, options could include:

Surgical intervention targeting the liver metastases;

Immunotherapy; or

Palliative care.

M6.2 Can these be mitigated, if so how?

M6.2 N/A

M6.3 What scenarios (differential assumptions) have been explicitly tested to generate best case, worst case and most likely total

M6.3 The costs set out in M3.1 is based on the scenarios developed around the number of patients and the per patient costs.


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cost scenarios? The cost saving of c. £1.1m is based on:

22-23 patients no longer receiving chemosaturation at a cost of c. £48k per patient.

This could range between c. £0.5m and £1.7m when using the low and high per patient estimates in M2.1. The cost pressure from an increase in comparator activity of c. £0.5m - £0.6m is based on:

8-10 patients receiving TACE at a cost of c. £16k per patient; and

13-14 patients receiving systemic therapy, where:

50% receive systemic chemotherapy at a cost of c. £4k per patient; and

50% receive systemic chemotherapy and immunotherapy at a cost of c. £57k per patient.

This could range between c.£0.4 - £0.8m when using the low and high per patient estimates in M2.1.

M7 Value for Money M7.1 What evidence is available that the treatment is cost effective? e.g. NICE appraisal, clinical trials or peer reviewed literature

M7.1 No evidence demonstrated

M7.2 What issues or risks are associated with this assessment? e.g. quality or availability of evidence

M7.2 No evidence demonstrated

M8 Cost Profile M8.1 Are there non-recurrent capital or revenue costs



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associated with this policy? e.g. Transitional costs, periodical costs

M8.2 If so, confirm the source of funds to meet these costs


i Macmillan.org.uk, (2016). Ocular melanoma (melanoma of the eye) - Cancer Information - Macmillan Cancer Support. [online] Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Eye/Melanomaoftheeye.aspx [Accessed 4 Jan. 2016].

ii This accounts for the population of England in the UK as a whole (84% of the 500-600). ONS (2015) Population estimates for England and the UK.

iii Policy proposition

iv Ocular Melanoma Foundation (2015).

v Patients may be suitable for chemosaturation provided that they are reasonably fit and have more than a 60% burden of liver disease (i.e. the cancer is taking up over 60% of the liver). Alternatively, patients may be unsuitable if they have significant cardiac or respiratory disease, brain metastasis (as high risk of bleeding during procedure), an abnormal liver anatomy (that would not allow the catheter to pass through), clotting disorders) that increase risk of bleeding). Based on discussions with the policy working group.

vi Graell, A., Caminal, JM., Masuet, C., Arias, L., Rubio, M., Pujol, O., Arruqa, J. (2007). Age distribution of uveal melanoma and its relationship to survival. Arch Soc Esp Oftalmol. 2007 Jun;82(6):343-7. [Online] Available at: http://www.ncbi.nlm.nih.gov/pubmed/17573643

vii Based on: Singh, A., Sisley, K., Xu, Y., Li, J., Faber, P., Plummer, S., Mudhar, H., Rennie, I., Kessler, P., Casey, G. and Williams, B. (2007). Reduced expression of autotaxin predicts survival in uveal melanoma. British Journal of Ophthalmology, 91(10), pp.1385-1392.

viii Based on discussion with the policy working group

ix NICE Guidance. (2013). Chemosaturation via percutaneous hepaticartery perfusion and hepatic vein isolation for primary or metastatic liver cancer (IPG488).

x Policy proposition

xi Based on discussions with the policy working group.

xii Based on discussions with the policy working group.

xiii Currently patients are recommended chemosaturation by NICE only within the context of research. Based on discussions with the policy working group.


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xiv NICE IP 1062 [IPG488]. IP overview: Chemosaturation via percutaneous hepatic artery perfusion and hepatic vein isolation for primary or metastatic cancer of the liver. [online] Available at: http://www.nice.org.uk/guidance/ipg488/evidence/chemosaturation-via-percutaneous-hepatic-artery-perfusion-and-hepatic-vein-isolation-for-primary-or-metastatic-liver-cancer-overview2 [Accessed 4 Jan. 2016].

xv Dacarbazine is the conventional first line chemotherapeutic agent used to treat liver metastases secondary to ocular melanoma. However, only < 5% of patients respond to systemic chemotherapy as it is usually not tolerated. (Source: Policy Proposition)

xvi Based on discussions with the policy working group

xvii Jovanovic et al. (2013). Ocular melanoma: an overview of the current status. Int J Clin Exp Pathol. 2013; 6(7): 1230–1244. [Online] Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3693189/

xviii Although the incidence of conjunctival melanoma is increasing (Jovanovic et al, 2013), it is not associated with metastasis and has not therefore been included in the disease incidence projection.

xix Population growth figures are derived for over 18s from ONS (2012) population projections.

xx Demographic growth projections are derived from ONS (2012) population projections for adults.

xxi Based on discussions with the policy working group.

xxii Based on discussions with the policy working group.

xxiii High Dependency Unit

xxiv Intensive Care Unit

xxv Based on discussions with the policy working group.

xxvi Based on discussions with the policy working group.

xxvii Based on discussions with the policy working group

xxviii Based on HRG code: RC31Z (IR Procedures - Hepatobiliary – Major), RC32Z (IR Procedures - Hepatobiliary – Intermediate) and RC33Z (IR Procedures - Hepatobiliary – Minor) from the 2014/15 national tariff. The spell tariff is £4,568, or c. £4,945 with a includes a market forces factor (MFF) uplift of 10%, and an efficiency factor of -3.5% and inflation rate of 1.9% for 2015/16 prices.

xxix Based on discussions with the policy working group.

xxx Please refer to Section 3.2 of VAT Notice 701/557 (https://www.gov.uk/government/publications/vat-notice-70157-health-professionals-and-pharmaceutical-products/vat-notice-70157-health-professionals-and-pharmaceutical-products)

xxxi Based on discussions with the policy working group.


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xxxii The tariffs for CT scans vary dependent on the number of areas and whether the scan is with or without contrast. This is from the 2014/15 national tariff and includes a market forces factor (MFF) uplift of 10%, In 2015/16, an efficiency factor of -3.5% and inflation rate of 1.9% are applied to all costs paid via tariff.

xxxiii The tariffs for MRI scans vary dependent on the number of areas and whether the scan is with or without contrast. This is from the 2014/15 national tariff and includes a market forces factor (MFF) uplift of 10%, In 2015/16, an efficiency factor of -3.5% and inflation rate of 1.9% are applied to all costs paid via tariff.

xxxiv The tariffs for CT scans vary dependent on the number of areas and whether the scan is with or without contrast. This includes a market forces factor (MFF) uplift of 10%, In 2015/16, an efficiency factor of -3.5% and inflation rate of 1.9% are applied to all costs paid via tariff.

xxxv This applies a market forces factor (MFF) uplift of 10% to the tariff in 2014/15 of £2,021. In 2015/16, an efficiency factor of -3.5% and inflation rate of 1.9% are applied to all costs paid via tariff.

xxxvi NHS UCL Hospitals. Provider to provider services 2014/15 Tariff. [Online] available at: https://www.uclh.nhs.uk/aboutus/wwd/Documents/Provider%20to%20Provider%20Tariff%202014-15.pdf [Accessed 12 Jan. 2016]

xxxvii Based on discussions with the policy working group. It is estimated that c.20% of patients would receive 1 cycle, whereas c.80% would receive a second cycle.

xxxviii Based on discussions with the policy working group

xxxix The lower bound assumes each patient receives two CT scans at a cost of £77 each. The upper bound assumes four MRI scans at a cost of £330 each.

xl Please note that figures are rounded to the nearest £1,000.

xli The tariffs for CT scans vary dependent on the number of areas and whether the scan is with or without contrast. This is from the 2014/15 national tariff and includes a market forces factor (MFF) uplift of 10%, In 2015/16, an efficiency factor of -3.5% and inflation rate of 1.9% are applied to all costs paid via tariff.

xlii The tariffs for MRI scans vary dependent on the number of areas and whether the scan is with or without contrast. This is from the 2014/15 national tariff and includes a market forces factor (MFF) uplift of 10%, In 2015/16, an efficiency factor of -3.5% and inflation rate of 1.9% are applied to all costs paid via tariff.

xliii Based on HRG code: RC31Z (IR Procedures - Hepatobiliary – Major), RC32Z (IR Procedures - Hepatobiliary – Intermediate) and RC33Z (IR Procedures - Hepatobiliary – Minor) from the 2014/15 national tariff. The spell tariff is £4,568, or c. £4,945 with a includes a market forces factor (MFF) uplift of 10%, and an efficiency factor of -3.5% and inflation rate of 1.9% for 2015/16 prices.

xliv This is expected to include the cost of the device. (Source: based on discussions with the policy working group)

xlv Based on discussions with the policy working group

xlvi Based on discussions with the policy working group

xlvii Based on discussions with the policy working group

xlviii Based on discussions with the policy working group

xlix The lower bound assumes each patient receives two CT scans at a cost of £77 each. The upper bound assumes four MRI scans at a cost of £330 each.

https://www.uclh.nhs.uk/aboutus/wwd/Documents/Provider%20to%20Provider%20Tariff%202014-15.pdf


24

l Please note that figures are rounded to the nearest £1,000

li Based on the cost per 3 week cycle of dacarbazine of £53 (Source: Scottish Medicines Consortium (2015), “ipilimumab 5mg/mL concentrate for solution for infusion (Yervoy®)” [available online] https://www.scottishmedicines.org.uk/files/advice/ipilimumab_Yervoy_FINAL_Oct_2014_Amended_24.10.14_for_website.pdf) and 6 months of 3 weekly delivery of chemotherapy (Source: 2014/15 National tariff, HRG code SB14Z and SB15Z. Prices include a 10% MFF uplift, an efficiency factor of -3.5% and an inflation uplift of 1.9%).

lii Based on the estimated costs for systemic chemotherapy and immunotherapy costs per 6 months for either ipilimumab or pembrolizumab (based on discussions with the policy working group) from Scottish Medicines Consortium (2015), “pembrolizumab 50mg powder for concentrate for solution for infusion (Keytruda®)”, [available online] https://www.scottishmedicines.org.uk/files/advice/pembrolizumab__Keytruda___FINAL_October_2015_SMC1086_for_website.pdf.

liii Based on discussions with the policy working group.

liv This is based on the ‘mid’ cost estimate in M2.1.

lv This assumes that 8-10 patients would instead receive TACE, and the remainder would receive systemic therapy (50% with immunotherapy and 50% without). ‘Mid’ cost estimates from M2.1 are used.

lvi Please note that figures may not sum due to rounding.

lvii Based on discussions with the policy working group.

https://www.scottishmedicines.org.uk/files/advice/ipilimumab_Yervoy_FINAL_Oct_2014_Amended_24.10.14_for_website.pdf